Someone I know has been talking about how there is a huge factory in China that supplies the US with a significant fraction of its annual caffeine import, and that supposedly no one is allowed to enter the factory to inspect what's going on.

She claims that because no one is allowed into the factory to inspect it and because testing of imported food chemicals in the US is infrequent, we can't know for sure how much caffeine is going into our energy drinks, or whether they are lacing it with impurities. As evidence for this, she offered anecdotal evidence of people reacting differently to energy drinks with the same caffeine content, as well as referencing a supposed historical laxity in chemical assaying of imported chemicals in the food industry.

I have been having trouble verifying or denying her claims. The best I have been able to find is a reference to Caffeinated: How Our Daily Habit Helps, Hurts, and Hooks Us, where a book review mentions that

"Refused access to the world’s largest synthetic caffeine factory in China, Carpenter notes that the industry is far from transparent; inspections are rare, and conditions are not always sanitary.

Her claims strike me as incredibly farfetched, primarily for the reason that as far as I was aware, synthetic caffeine is usually supplied in near-100% purity, so it would be incredibly easy to detect any deviation above a few parts per thousand (let alone deviations on the order of ~500 parts per thousand like she is claiming) by a routine chemical assay.

However, I have no experience in how chemical assaying is done in the United States, and in particular how often (and how randomly-scheduled) chemical testing is done on imported synthetic food additives, and so I have not been able to get any definitive answers on whether these claims are plausible or not.

So, in essence:

What are the regulatory guidelines imposed by the FDA on the frequency and scope of chemical assaying of imported pure synthetic food additives like caffeine?

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    Not enough for an answer, but I can say that the same amount of caffeine can have different effects on different people. Factors such as body mass, sleep, current hydration and even gender can make drastic differences in how one's body and mind react to caffeine. This article really only covers the gender aspect, but I'm sure it wouldn't be too hard to find sources on the effects of drugs/chemicals on people of different sizes, etc. sciencedaily.com/releases/2008/12/081222113526.htm – Dryden Long Mar 28 '14 at 21:16

In February 2013, the FDA issued a warning letter to an importer of caffeine powder.

In it, the FDA reports that a number of violations to the FDA standards were observed for several imported ingredients.

Further, your firm failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging and/or labeling and distribution as dietary supplements are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, your firm did not establish specifications for the products SUPER MSM (Methyl-Sulfonyl-Methane) 1000mg, Inositol 500mg, and White Crystalline Powder Caffeine (1/2 oz.) your firm receives in bulk for repackaging and labeling as dietary supplements.

In general, the FDA complained that the importer accepted the claims of the supplier about the contents of the imported ingredients without (a) checking the ingredients themselves and (b) without ensuring that the suppliers are reliable in performing their analyses of the content:

In order to rely on a certificate of analysis from a supplier of the component, the following requirements of 21 CFR 111.75(a)(2)(ii) must be met: (A) qualify the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations; (B) the certificate of analysis must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) maintain documentation of how the supplier was qualified; (D) periodically re-confirm the supplier’s certificate of analysis; and (E) the documentation setting forth the basis for qualification (and re-qualification) of any supplier must be reviewed and approved by quality control personnel.

This letter demonstrates that the FDA is concerned about the quality of ingredients, including caffeine powder, imported from overseas, that it has standards to address those concerns, and that it (sometimes) takes action against infringements, even without needing to frequently inspect foreign factories.

However, this is only one example of the FDA taking action. It doesn't demonstrate that the FDA is consistently monitoring all importers or that its concerns are taken seriously by the suppliers. (It also demonstrates that, at least in the short term, there are suppliers that don't treat the issue with the same care as the law expects.)

Note: Your friend's claim and the book reviewer's claims contradict. Your friend claims no-one is allowed to inspect. The book reviewer cites that inspections are "rare", and that the author of a hostile book was not granted access to the factory, which is very different to refusing access to inspectors.

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  • It would be great to figure out the frequency at which the FDA actually tests imported chemical products. That would help determine whether the letter found is somewhat anecdotal or exceptional. – ChrisR Mar 29 '14 at 8:48
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    @ChrisR: The published FDA stats almost answer that, but don't really. – Oddthinking Mar 29 '14 at 11:04

because no one is allowed into the factory to inspect it, we can't know for sure how much caffeine is going into our energy drinks, or whether they are lacing it with impurities

It is possible to sample any product that has been "introduced or delivered for introduction in interstate commerce": http://www.fda.gov/ICECI/Inspections/IOM/ucm122523.htm

For example, the FDA uses in-transit samples and undercover buys.

Inability to inspect the factory (and I don't know if this is actually true) would not preclude testing at the point of sale or during delivery.

Further, from this description of the Food Safety Modernization Act:

Food facilities are required to register with FDA biennially.
Food from an unregistered facility may not be imported into the United States or introduced into interstate or intrastate commerce.
Food facilities will be inspected with greater frequency, and domestic facilities will be inspected at least once every 5 years.

Also, see the FDA's own description.

About denying the FDA access to the facility:

FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

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  • Yes, it's obviously false, and that was my primary objection to her claims. But she then asked me, "how often are these imported products tested?". I briefly skimmed the informative FDA link you provided, but didn't see any requirements as to how often imported samples are required to be collected (unless I missed it), as it mostly seems to pertain to the legal aspects of how sample testing has to be done. – DumpsterDoofus Mar 28 '14 at 17:51
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    From the wording of your question, I understood that her claim was that the testing couldn't be done. Does she make a different claim that it actually isn't being done? – user5582 Mar 28 '14 at 17:52
  • She admits that testing can be done here, but she seemed to think that it wasn't done often enough to be convincing, which was my main concern. I can edit my question to reflect this. – DumpsterDoofus Mar 28 '14 at 17:54
  • (Edited question to make it apparent that it's the frequency of import testing that's in question). – DumpsterDoofus Mar 28 '14 at 18:02
  • I updated the answer to also address her claims that the FDA was denied access. – user5582 Mar 28 '14 at 18:07

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